patients with KRAS G12C+ non small cell lung cancer and brain metastases
Conditions
Brief summary
Brain Metastases Objective Response Rate (RANO-BM criteria)
Detailed description
There are two secondary key endpoints: brain metastase disease control rate (RANO-BM) AND median CNS progression-free survival (RANO-BM)., Extracranial objective response rate (ORR) and disease control rate (DCR) (RECIST 1.1), Median extracranial progression-free survival (PFS) (based on RECIST 1.1), Median overall PFS (based on RANO-BM for BM and RECIST 1.1 for extracranial lesions), Median overall survival (OS), Quality of life (EORTC QLQ-BN20 and EORTC QLQ-C30), Safety (CTCAE v5.0)
Interventions
DRUGJDQ443
Sponsors
University Hospital Maastricht
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brain Metastases Objective Response Rate (RANO-BM criteria) | — |
Secondary
| Measure | Time frame |
|---|---|
| There are two secondary key endpoints: brain metastase disease control rate (RANO-BM) AND median CNS progression-free survival (RANO-BM)., Extracranial objective response rate (ORR) and disease control rate (DCR) (RECIST 1.1), Median extracranial progression-free survival (PFS) (based on RECIST 1.1), Median overall PFS (based on RANO-BM for BM and RECIST 1.1 for extracranial lesions), Median overall survival (OS), Quality of life (EORTC QLQ-BN20 and EORTC QLQ-C30), Safety (CTCAE v5.0) | — |
Countries
Netherlands
Outcome results
None listed